NCT02433314No Longer Available不适用
An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects six (6) months of age and older
- •Subjects who have:
- •Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to the institution's standard of care, and;
- •Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AEDs), according to the institution's standard of care, and;
- •Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agents and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents but not in an EEG burst or seizure suppression pattern.
排除标准
- •Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
- •Children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder
- •Subjects who have any of the following:
- •a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned;
- •severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
- •fulminant hepatic failure;
- •no reasonable expectation of recovery or life-expectancy of less than 30 days.
- •Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol
研究者
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